- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00378989
The Effectiveness of Health Advice and Occupational Health Intervention on Work Ability
The Effectiveness and Cost-effectiveness of Health Advice and Occupational Health Intervention on Work Ability. Two Randomised Trials.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
The study design is a longitudinal cohort study with two embedded randomised trials. The risk of sickness absence is classified on the basis of self-administered questionnaires, on the basis of a priori defined cut-off limits. Two randomised trials are performed in the subgroups of 'High Risk´ and 'Increased Risk´ of sickness absence. The study is performed within one corporation in Finland. All employees with permanent job and age between 18 and 60 years are invited to participate.
The worker's own occupational nurses and physicians execute the occupational health program for workers at 'High Risk´ for sickness absence. The employees in the "High Risk" intervention group receive a personal feedback of their health survey results in a letter, in which they are also invited to a consultation at the OHS. The main purpose of the consultation, during which the individual findings of the health survey are available for the OHS professionals, is the construction of an action plan, and if appropriate, referral to a medical specialist, or psychologist. The employees in the 'High Risk´ control group receive care as usual.
The intervention for workers at 'Increased Risk´ for sickness absence is executed as medical counselling over the telephone. The employees in the 'Increased Risk´ intervention group receive a personal feedback of their questionnaire results in a letter, in which they were also invited to call the phone advice centre in order to receive medical advice. The employees in the 'Increased Risk´ control group receive care as usual.
Sickness absence data is obtained from the employer's records, the baseline covering the one-year period before the intervention and the follow-up covering the one-year period after the intervention. Sickness absences are obtained without medical diagnoses. The study participants also fill in a health questionnaire including, among other questions, healthcare utilization variables at the one-year follow-up.
We will carry out an intention to treat analysis. We will use analysis of covariance (ANCOVA) to analyse sickness absence outcomes at 12 months, with corresponding baseline values and risk / treatment group as covariates. Economic evaluation will be performed alongside the randomised controlled trial within the 'High Risk´ group.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Espoo, Finland, 20600
- Evalua International Ltd. Oy
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Permanent job
- Age 18 to 60 years
Exclusion Criteria:
- Pension granted
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
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No Intervention: Control
Care as usual
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Active Comparator: Intervention
A letter with personal feedback of the results of a health risk appraisal and invitation to a consultation at the occupational health services.
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Consultation at the occupational health services
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
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Sickness absence during the 12-month follow-up
Time Frame: 12 months
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12 months
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Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Simo P Taimela, MD, PhD, Evalua International
Publications and helpful links
General Publications
- Taimela S, Laara E, Malmivaara A, Tiekso J, Sintonen H, Justen S, Aro T. Self-reported health problems and sickness absence in different age groups predominantly engaged in physical work. Occup Environ Med. 2007 Nov;64(11):739-46. doi: 10.1136/oem.2006.027789. Epub 2007 Feb 15.
- Taimela S, Malmivaara A, Justen S, Laara E, Sintonen H, Tiekso J, Aro T. The effectiveness of two occupational health intervention programmes in reducing sickness absence among employees at risk. Two randomised controlled trials. Occup Environ Med. 2008 Apr;65(4):236-41. doi: 10.1136/oem.2007.032706. Epub 2007 Aug 6.
- Taimela S, Justen S, Aronen P, Sintonen H, Laara E, Malmivaara A, Tiekso J, Aro T. An occupational health intervention programme for workers at high risk for sickness absence. Cost effectiveness analysis based on a randomised controlled trial. Occup Environ Med. 2008 Apr;65(4):242-8. doi: 10.1136/oem.2007.033167. Epub 2007 Oct 12.
- Taimela S, Aronen P, Malmivaara A, Sintonen H, Tiekso J, Aro T. Effectiveness of a targeted occupational health intervention in workers with high risk of sickness absence: baseline characteristics and adherence as effect modifying factors in a randomized controlled trial. J Occup Rehabil. 2010 Mar;20(1):14-20. doi: 10.1007/s10926-009-9221-0.
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- EVA2XRCT
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